Jul 12, 2009 - cut-off value of 4.5% of total time with pH < 4 during a 24-hour ...... Noordzij JP, Khidr A, Desper E, Meek RB, Reibel JF, Levine PA. Correlation ...
GUIDELINES IN FOCUS
Gastroesophageal reflux disease: diagnosis ©2011 Elsevier Editora Ltda. Este é um artigo Open Access sob a licença de CC BY-NC-ND
AUTHORS Federação Brasileira de Gastroenterologia, Sociedade Brasileira de Endoscopia Digestiva, Colégio Brasileiro de Cirurgia Digestiva, Sociedade Brasileira de Pneumologia e Tisiologia.
PARTICIPANTS Aloisio Carvalhaes, Angelo Paulo Ferrari Júnior, Antonio Frederico Magalhães, Ary Nasy, Celso Mirra Paula e Silva, Cláudio L.Hashimoto, Décio Chinzon, Edson Pedro da Silva, Eduardo G. H. Moura, Eponina Maria Oliveira Lemme, Farid Butros Iunan Nader, Fauze Maluf Filho, Gerson R. de Souza Domingues, Igelmar Barreto, Isac Jorge Filho, Ismael Maguilnik, Ivan Cecconello, Jaime Natan Eisig, Joaquim Prado P. de Moraes-Filho, Joffre Rezende Filho, José Carlos Del Grande, José Luiz Pimenta Modena, José Roberto Almeida, Lilian R. O. Aprile, Luciana Camacho-Lobato, Luciana Dias Moretzohn, Marcelo de Souza Cury, Marcio Matheus Tolentino, Marco Aurelio Santo, Marcos Kleiner, Marcus Túlio Haddad, Maria do Carmo Friche Passos, Olavo Mion, Osvaldo Malafaia, Paulo Roberto Savassi Rocha, Rafael Stelmach, Ricardo Aires Correa, Ricardo Correa Barbuti, Richard Gursky, Rimon Sobhi Azzam, Roberto El Ibrahim, Rubéns Antonio Aissar Sallum, Roberto Oliveira Dantas, Schilioma Zaterka, Sérgio Gabriel Silva de Barros, Tomas Navarro Rodriguez, Ulysses G. Meneghelli, Wilson Modesto Polara, Grupo de Esôfago e Motilidade da Disciplina de Gastroenterologia Clínica do Departamento de Gastroenterologia da FMUSP, Sociedade Brasileira de Motilidade Digestiva
FINAL
VERSION
July 12, 2009
CONFLICT OF INTEREST Chinzon D: has received reimbursement from Janssen Companies for attending conferences, consulting and speaker’s fees sponsored by Janssen, AstraZeneca, and Medley. Lemme EMO: has received speaker’s fees sponsored by AstraZeneca and honoraria for research sponsored by Nycomed. Moraes Fo JPP: received reimbursement for attending a symposium sponsored by the companies AstraZeneca, Nycomed and Medley, speaker’s fee sponsored by AstraZeneca and Nycomed, funding for organizing educational activities sponsored by Nykomed, Aché, and AstraZeneca. Rezende Filho J: received speaker’s fees sponsored by Nycomed. Mion O: received speaker’s fees sponsored by AstraZeneca. Stelmach R: received speaker’s fees for organizing teaching activities, for research, and consulting sponsored by AstraZeneca, Ache, Bayer Shering Plough, BoerhingerInghelhein, Eurofarma, GlaxoSmithKline, Novartis and Mantercorpe. Barbut RC: has received funding for lec-
tures, research, teaching organization, and consulting sponsored by AstraZeneca, Ache and Medley. Dantas RO: received speaker’s fees sponsored by AstraZeneca. Zaterka S: has received funding for consulting and training organization sponsored by Janssen-Cilag. Navarro T: has received funding for lectures, teaching activities organization, research, and consulting sponsored by AstraZeneca. DESCRIPTION
OF THE EVIDENCE COLLECTION METHOD
A search was performed in the databases EMBASE, SciELO/LILACS, PubMed/MEDLINE, and Cochrane Library using the following words: signs, symptoms, endoscopy, gastroesophageal reflux, GERD, heartburn, NERD, GERD, esophagus, hydrogen-ion concentration, esophageal pH monitoring, ion-selective electrodes, bravo, capsules, capsule endoscopy, electric impedance, extra-esophageal, asthma, atypical symptoms, chest pain, cough, globus sensations, hoarseness, otorhinolaryngologic diseases, pain, respiratory tract diseases, laryngitis, vomiting, biopsy, histology, dilatat*, DIS, intercellular, space*, endosonographies, echo, echo endoscopies, endoscopies, ultrasonic endoscopy, echo-endoscopy, echo endoscopy, echo-endoscopies, ultrasonic, ultrasonic endoscopies, ultrasonography, endoscopic, endoscopic ultrasonography, endoscopic ultrasonographies, ultrasonographies, endoscopic, endosonography, sonography, pulmonary fibrosis, sleep disorders. About 12,000 publications were retrieved using the filters: humans, sensitiv*, sensitivity and specificity, diagnos*, diagnosis, diagnostic, diagnosis, differential, randomized controlled trial, randomized AND controlled AND trial, clinical AND trial, clinical trials, random*, random allocation, therapeutic use, epidemiologic methods, relative AND risk*, relative risk, risks, cohort studies, cohort AND stud*, prognos*, first AND episode, cohort. Fifty-one studies were selected to support this Guideline, which conferred the degree of recommendation A or B. These recommendations were adapted to our scenario. Experts representing major Brazilian universities including clinical gastroenterologists, digestive surgeons, pathologists, endoscopists, otolaryngologists and pulmonologists attended the meetings to discuss and set these guidelines.
DEGREE OF RECOMMENDATION AND STRENGTH OF THE EVIDENCE A: Experimental or observational studies of higher consistency. B: Experimental or observational studies of lower consistency. C: Case reports (non-controlled trials). D: Opinion without critical evaluation, based on consensus, physiological studies, or animal models. Rev Assoc Med Bras 2011; 57(5):489-497
489
GUIDELINES IN FOCUS
OBJECTIVES Due to the high prevalence of gastroesophageal reflux disease (GERD), differences in the form of clinical presentation, economic impact, consequences of impaired quality of life, and cost of clinical and laboratory research, international consensus meetings have been encouraged. On the other hand, the diagnostic and therapeutic management of GERD has varied from center to center, which is an important factor in the search for scientific evidence on the subject and served as motivation for the development of this Guideline, which seeks to answer 14 questions relevant to the clinical diagnosis of GERD.
INTRODUCTION Gastroesophageal reflux disease (GERD) is one of the most common disorders in medical practice. Under the same designation, the disease presents distinct clinical conditions such as occasional heartburn, chronic cough, and refractory asthma. As for diagnosis, the endoscopic conditions are very diverse, ranging from the absence of injury to the presence of major complications such as Barrett’s esophagus. GERD is a chronic condition resulting from the retrograde flow from part of gastroduodenal contents into the esophagus and/or organs adjacent to it, resulting in a variable spectrum of esophageal/extra-esophageal signs and/or symptoms, with or without tissue damage.
1. SHOULD ADULT TIONS (HEARTBURN
PATIENTS WITH
GERD
MANIFESTA-
AND/OR REGURGITATION), WITHOUT
SYMPTOMS OR WARNING SIGNS
(WEIGHT
LOSS, BLEEDING,
SORE THROAT, DYSPHAGIA ETC.) BE SUBMITTED TO UPPER DIGESTIVE ENDOSCOPY
(UDE)
BEFORE TREATMENT?
In patients with a mean age of 45 years, the presence of heartburn and heartburn symptoms increases the risk for diagnosis of GERD, odds ratio (OR): 1.9 (1.3 to 2.7) and 1.6 (1.0 to 2.4), respectively. And the presence of abdominal pain, chest pain, and nausea symptoms reduces the risk for diagnosis of GERD, OR: 0.6 (0.4 to 0.9); 0.5 (0.3 to 0.8); and 0, 7 (0.4 to 0.9), respectively (A)1. In patients with a mean age of 54 years, the presence of pyrosis (or heartburn) symptom has a sensitivity of 67%, specificity 77%, and positive likelihood ratio of 2.83 in the diagnosis of GERD. And the absence of pyrosis (or heartburn) symptom has a sensitivity of 33%, specificity of 24%, and negative likelihood ratio of 0.44 to exclude the diagnosis of GERD (A)2. The use of the reflux disease questionnaire (RDQ) in patients with a mean age of 41 years, with symptoms of GERD, provides a sensitivity of 87.5% and specificity of 75.7%: positive likelihood ratio of 3.6 for diagnosis of GERD and negative ratio of 0.16 to exclude the diagnosis (A)3. 490
Rev Assoc Med Bras 2011; 57(5):489-497
In patients with a mean age of 42 years and symptoms of GERD, the use of scale with seven symptoms, compared to EGD, provides sensitivity, specificity, likelihood ratio of 74.3%, 71.6%, 2.61, and 0.36, respectively (A)4. Symptomatic response after four weeks of empirical treatment with esomeprazole 40 mg (86.4%) in patients with GERD is equivalent to the treatment preceded by UDE (87.5%). Similarly, after maintenance treatment with esomeprazole 20 mg (24 weeks), a similar proportion of patients remained responsive (71.8% versus 68.3%), respectively (A)5. RECOMMENDATION In populations with GERD prevalence of 12% to 25%, the presence of heartburn and regurgitation symptoms increases the diagnostic confirmation to about 40%. The upper digestive endoscopy does not alter the clinical course when compared to empirical treatment.
2. PATIENTS
WITH TYPICAL SYMPTOMS AND FREQUENCY
GREATER THAN TWICE A WEEK FOR A PERIOD OF NOT LESS
THAN FOUR WEEKS WITH NORMAL UPPER DIGESTIVE ENDOSCOPY TEST; IS IT
GERD?
In patients (mean age 47 years) with symptoms of GERD and negative UDE, the score of symptoms classified as moderate and severe does not identify GERD patients; sensitivity of 82%, specificity of 22%, positive likelihood ratio of 1.05, and negative ratio of 0.81. And the test with lansoprazole 60 mg daily for seven days in the diagnosis of GERD gives a sensitivity of 97%, specificity of 6%, positive likelihood ratio of 1.03, and negative ratio of 0.03 (A)6. The use of RDQ in patients with a mean age of 41 years with symptoms of GERD provides a sensitivity of 87.5%, specificity of 75.7%, with positive likelihood ratio of 3.6 for diagnosis of GERD and negative ratio of 0.16 to exclude the diagnosis (A)3. RECOMMENDATION In patients with non-erosive GERD, with 20% prevalence, the use of symptom score (severe or moderate) increases the diagnostic certainty by up to 40%.
3. SHOULD
PATIENTS WITH HEARTBURN AND UPPER DI-
GESTIVE ENDOSCOPY SHOWING NO EROSIONS BE SUBMITTED TO ESOPHAGEAL PH MONITORING TO CONFIRM THE DIAGNOSIS?
In patients with upper gastrointestinal endoscopy without esophageal erosions, with typical symptoms of reflux, mean age 34.4 years, the esophageal pH-metry using a cut-off value of 4.5% of total time with pH
